Friday, March 09, 2012

Novartis Case by Supreme Court and Evergreening of Patent

NGO's, activists and others protested recently outside Novartis's annual shareholders meeting in Basel, Switzerland, and also at Novartis offices in New York, Washington, and Cambridge, Mass., demanding that the company drop the case. Demonstrators complain that Novartis is trying to stop generic reproductions of its drugs that millions in poor countries depend on. The problem started when the Chennai HC approved the Govt. of india's decision not to grant patent to Gleevec. Novartis appealed in the Supreme Court of India, and the case has been winding through for the last six years and now the Court is preparing to hear final arguments this month. It represents a high-stakes showdown between defenders of intellectual property rights, who say the generic knockoffs stifle innovation by drug makers, and Indian drug companies and international aid groups, who warn that a ruling in favor of Novartis could dry up the global supply of inexpensive medicines to treat AIDS, cancer, and other diseases. The said drug is approved by United States Food and Drug Administration in 2001. The drug, which is sold outside the United States by Novartis as Glivec and known generically as imatinib mesylate, has turned deadly chronic myelogenous leukemia into a manageable chronic disease for many patients. It is also used to treat a form of gastrointestinal cancer.

India is the world's third-largest drug producer by volume and exports about $10 billion worth of generic medicines every year, more than any other country, primarily selling to other fast-growing developing countries that are expected to become significant new markets for big drug companies. The decision could also help determine how much Western drug companies invest in India at a time when they want to increase sales in emerging markets to compensate for slowing business in the United States and Western Europe. India resumed granting drug patents in 2005 as part of a World Trade Organization agreement on patents, but medicines created before 1995 did not qualify. And that's where the disagreement arises over Gleevec The case before the Supreme Court revolves around Section 3(d) of The Indian Patent Act 1970, that prohibits a newer form of a known substance from receiving a patent unless it significantly improves the medicine's "efficacy," or effectiveness. The standard was aimed at preventing a practice known as evergreening, in which a pharmaceutical company makes minor changes to existing drugs and earns new patents, thereby providing many more years of protection from generic competition. Gilead Sciences, for instance, is appealing India's rejection of a patent application for its drug Viread, or tenofovir disoproxil fumarate, which is used to treat H.I.V. infection. And Roche is fighting several court cases to uphold its patent on the anticancer drug Tarceva, or erlotinib, that Indian drug makers argue does not meet the effectiveness standard. Courts have allowed generic versions of that drug to be sold in India while the case is being litigated. India's patent law does not define "efficacy" or say how it should be measured. Novartis is arguing that the term should encompass modifications that might make a drug safer or easier to use, not just more effective in treating a disease. It says more than 40 other countries have granted a patent on Gleevec.Novartis maintains that the current version of Gleevec is 30 percent easier for the body to absorb than an older chemical that it developed but never marketed as a drug. The older compound was patented in the United States, Europe and elsewhere in the early 1990s, but not in India because India did not allow patents on drugs at that time.

Generally when drug companies discovered a compound that fits some specifications in a test tube or animal study, they patented it to protect themselves from copycats. But that initial compound is often not suitable for use as a drug because it might not be absorbed into the bloodstream well enough, or it might be chemically unstable, or unsafe. So, modifications are made until a suitable form is found, and that new form is then also patented. The United States and European Union often grant patents for chemical modifications of existing drugs.The chances are there that the victory for Novartis would not shut off the production of generic Gleevec or of other existing generics, but could impede the ability of Indian manufacturers to develop generic versions of future drugs. The decision of the case will clarify about what kind of innovation is and is not patentable in India. The court while interpreting Section 3 (d) of the Patent Act 1970, must keep in mind the balance of the need for innovation and public health.